COVID-19 Office Site Delivery Buprenorphine

us-doj-guidance-DEA-DC-030COVID-19 Office Site Delivery BuprenorphineGuidance

U. S. Department of Justice
Drug Enforcement Administration
8701 Morrissette Drive
Springfield, Virginia 22152
www.dea.gov
DEA-Registered Narcotic Treatment Program
Dear Registrant:
The Drug Enforcement Administration (DEA) previously issued a guidance document (Doc. No.
DEA078), posted on our website and dated April 7, 2020, providing greater flexibility in how
Opioid Treatment Programs (OTPs) may deliver take-home doses of methadone to their patients. In
light of the nationwide public health emergency declared by the Secretary of Health and Human
Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID-19),
DEA is now extending the same flexibility to OTPs in how they deliver take-home doses of
buprenorphine.1 As with methadone, DEA is temporarily allowing OTPs to regularly use the same
off-site location to deliver take-home buprenorphine doses to their patients without separately
registering that location with DEA, subject to the same conditions as expressed in the April 7
methadone guidance document.
Under normal circumstances, such off-site locations would have to be separately registered with
DEA if used regularly by the OTP to deliver take-home doses of controlled substances, as more fully
described in the April 7 methadone guidance document. However, during the public health
emergency or until this guidance document is withdrawn or modified by DEA (whichever comes
first), DEA is granting additional flexibility to permit OTPs to dispense take-home doses of
buprenorphine without obtaining a separate registration for the locations at which such deliveries
occur.
In the same manner as described in the April 7 methadone guidance document, DEA will
exercise its authorities to permit OTPs to regularly use off-site locations located in the same state in
which the OTP is registered with DEA to deliver take-home doses of buprenorphine to their patients
without separately registering those locations. The same limitations as applied to methadone will
also apply to off-site locations to dispense buprenorphine, and are as follows:
• 	Before using the unregistered off-site location to dispense buprenorphine, the OTP must
first contact its State Opioid Treatment Authority (SOTA), and receive the SOTA’s
approval to use the offsite location.
1 For additional information regarding DEA’s and SAMHSA’s responses to COVID-19, please see
https://www.deadiversion.usdoj.gov/coronavirus.html and https://www.samhsa.gov/coronavirus. The Controlled
Substances Act (CSA) and DEA regulations refer to OTPs as Narcotic Treatment Programs (NTPs).
Complete printed PDF page 1
• 	Before using the unregistered off-site location to dispense buprenorphine, the OTP must
receive approval from the local DEA field office. Once the SOTA approves the location,
it should contact the local DEA field office. If the SOTA does not contact the DEA field
office, the OTP must contact the field office itself.2 The DEA field office may have
additional questions about the off-site location and may need to inspect it to ensure that it
does not present an unacceptable risk of diversion. Note, however, that if the DEA field
office has already approved the off-site location for dispensing methadone, it may also be
used to dispense buprenorphine without further approval from DEA.
• 	Each day, the OTP may only transport those take-home buprenorphine doses to the
unregistered off-site location that the OTP reasonably anticipates will be delivered to
patients that day. That is, the OTP should never transport a reserve of buprenorphine to
the off-site location.
• 	Any buprenorphine not delivered to patients by the OTP at the off-site location must be
returned to the OTP’s DEA-registered location the same day. No buprenorphine may be
stored at the off-site location when an OTP staff member is not present.
Please note that this guidance only applies to take-home doses of buprenorphine directly
dispensed by OTPs. This guidance is not intended for use by individual DEA-registered DATA-
waivered practitioners when prescribing buprenorphine to patients for dispensing from a pharmacy.3
In addition, this allowance does not extend to any off-site locations regularly used by OTPs to
provide daily doses of buprenorphine directly to patients who are not authorized to receive take-
home doses. Thus, DEA has concluded that such locations must continue to be separately registered
with DEA to ensure that they do not become sources of diversion.
The allowance set forth in this letter is granted to DEA-registered OTPs meeting these conditions
from April 28, 2020, through the duration of this public health emergency as declared by the
Secretary of HHS (unless this allowance is first modified or withdrawn by DEA).
We hope this information is helpful. For more information from SAMHSA please visit
www.samhsa.gov. For information regarding DEA’s Diversion Control Division please visit
2 DEA’s COVID-19 information webpage contains a link to the contact information of DEA local field offices. See
https://www.deadiversion.usdoj.gov/coronavirus.html.
3 The Controlled Substances Act permits practitioners to dispense narcotic drugs for opioid use disorder without
separately registering as an OTP by providing a waiver of this separate registration requirement for practitioners
dispensing schedule III, IV, or V narcotic controlled substances approved by the Food and Drug Administration
specifically for the use in maintenance or detoxification treatment. 21 U.S.C. 823(g)(2); 21 CFR 1301.28. Currently, the
only controlled substance meeting these criteria is buprenorphine. To qualify for such waiver to dispense buprenorphine
for maintenance or detoxification treatment outside of an OTP, the practitioner must meet the qualifications set by the
Substance Abuse and Mental Health Services Administration (SAMHSA). Practitioners who have met these SAMHSA
qualifications and obtained authorization from DEA to dispense buprenorphine for maintenance or detoxification
treatment are often referred to as “DATA-waived practitioners” (in reference to the Drug Addiction Treatment Act of
2000, which added 21 U.S.C. 823(g)(2) to the CSA). The guidance in this document does not apply to such
buprenorphine prescribing pursuant to a DATA waiver.
Complete printed PDF page 2
www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division, Policy Section at
(571) 362-3260 if you seek additional assistance regarding this or any other matter.
Guidance documents, like this document, are not binding and lack the force and effect of law,
unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative
agreement. Consistent with Executive Order 13891 and the Office of Management and Budget
implementing memoranda, the Department will not cite, use, or rely on any guidance document that
is not accessible through the Department’s guidance portal, or similar guidance portals for other
Executive Branch departments and agencies, except to establish historical facts. To the extent any
guidance document sets out voluntary standards (e.g., recommended practices), compliance with
those standards is voluntary, and noncompliance will not result in enforcement action. Guidance
documents may be rescinded or modified in the Department’s complete discretion, consistent with
applicable laws.
Sincerely,
Thomas W. Prevoznik
Deputy Assistant Administrator
Diversion Control Division
DEA087 – April 28, 2020
Complete printed PDF page 3

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